Sinusitis
Conditions
Brief summary
Study Design: A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.
Interventions
DEVICEStratus Microflow Ethmoid Spacer
The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects age 17 years or older * Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery) * Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
Exclusion criteria
* Age \< 17 years old * History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP \>21 mmHg) * Adequate anatomical distances for treatment * Patient received oral steroid treatment within two weeks prior to day of surgery * Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement * Sinonasal tumors or obstructive lesions * History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus * Contracted/underdeveloped ethmoid sinus * Dehiscent lamina orbitalis * Previous ethmoid surgery * Ethmoid mucocele * Extensive Nasal Polyps * Asthmatic patients with aspirin sensitivity * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline. | 10 weeks post-procedure | The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure) | 10 weeks post surgery | The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint. |
| Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg | 10 weeks post-procedure | Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of \> 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure). |
| Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline | 1 year | The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stratus Microflow Ethmoid Spacer Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not consent for extended follow-up | 13 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Stratus Microflow Ethmoid Spacer |
|---|---|
| Age, Continuous | 47.24 years STANDARD_DEVIATION 14.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 63 |
| serious Total, serious adverse events | 2 / 63 |
Outcome results
Primary
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.
Time frame: 10 weeks post-procedure
Population: A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stratus Microflow Ethmoid Spacer | Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline. | -1.91 scores on a scale | Standard Deviation 1.94 |
Secondary
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
Time frame: 1 year
Population: The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stratus Microflow Ethmoid Spacer | Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline | -1.36 scores on a scale | Standard Deviation 1.27 |
Secondary
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
Time frame: 10 weeks
Population: The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stratus Microflow Ethmoid Spacer | Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline | -1.54 scores on a scale | Standard Deviation 0.99 |
Secondary
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.
Time frame: 10 weeks post surgery
Population: The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratus Microflow Ethmoid Spacer | Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure) | 0 participants |
Secondary
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of \> 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).
Time frame: 10 weeks post-procedure
Population: The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratus Microflow Ethmoid Spacer | Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg | 1 participants |